Examining the Impacts of Fidget Technology on Attention in Children With ADHD

ADHD Clinical Trial

Official title:

Do Fidget Instruments Enhance Attentional Control and Comprehension in 6-13 Year-olds With Attention Deficit Hyperactivity Disorder (ADHD)?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05384717
• Other study ID #: 22-0531
• Status: Completed
• Phase: N/A
• Start date: April 18, 2022
• Est. completion date: September 24, 2022

Study information

• Verified date: May 2022
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose: The purpose of this study is to investigate the usage of fidget technology and its effects on attention, working memory, and comprehension in children ages 6-13 with Attention Deficit Hyperactivity Disorder (ADHD). This study aims to examine the implications of fidget usage 2 different measures of attention; attentional control (working memory domain) and comprehension (recall, encoding, and recognition).

Participants: 6-13 year-old clients at 3-C Family Services, a private mental health clinic in Cary, NC, with a diagnosis of ADHD (Inattentive, Hyperactive, or combined types). Exclusion criteria: participants with an Intelligence Quotient (IQ) below 70 as estimated by referring 3-C clinical staff, or any history of psychosis.

Procedures (methods): This research will use a demographic and background collecting survey to gather relevant data about each participant. Parents will be asked to fill out a baseline ADHD Rating Scale-IV: Home Version (ADHD-RS), to account for their child's symptoms of ADHD over the past 6 months. Participants will be randomly assigned to one of 2 conditions, an experimental group where participants select a fidget, and a control group where participants are not provided a fidget. Fidget options will include a fidget spinner, pop-it, stress ball, and fidget cube as not all children would benefit from the same type of fidget equally. Participants in the experimental group will then be allowed to practice with and familiarize themselves with the fidget for 1 minute to decrease the attentional drain that the fidget may pose in its initial state.

After random assignment to either control or experimental group, participants in each group will then complete the same 2-back version of the N-back Attention Control Task (cognitivefun.net), and a video comprehension multiple choice test. After 3 minutes N-back scores will be recorded including visual correct ratio and visual response time scores. The video comprehension item is adapted from Lee and List, 2019. The video is a Ted Talk titled "The Survival of the Sea Turtle" ( https://www.youtube.com/watch?v=t-KmQ6pGxg4). Items in the multiple choice test will be aggregated to a score of percent correctness for each participant. Participants may request to have questions read to them by the research assistant present.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 24, 2022
• Est. primary completion date: August 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

Inclusion Criteria:

• Diagnosis of ADHD

Exclusion Criteria:

• Psychosis

• IQ under 70

Related Conditions & MeSH terms

• ADHD

Intervention

Other:
• Fidget Device
Fidget spinner, stress ball, pop-it, or fidget cube
• Control group
No intervention

Locations

Country	Name	City	State
United States	3-C Family Services	Cary	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	3-C Family Services

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lee, Hye Yeon & List, Alexandra. (2019). Processing of texts and videos: A strategy-focused analysis. Journal of Computer Assisted Learning. 35. 10.1111/jcal.12328

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	N-back Visual correct ratio	The N-Back task is a measure of working memory. Participants are presented a sequence of stimuli and must decide if the current stimulus is the same as the one presented two trials ago. Max value= 1, min value =0, higher scores are closer to 1	Day 1 (Up to 30 minutes)
Primary	N-back visual response time	The N-Back task is a measure of working memory. Participants are presented a sequence of stimuli and must decide if the current stimulus is the same as the one presented two trials ago. The lower the score the better (indicates less time to decide on n-back). For response time measure there is no minimum or maximum.	Day 1 (Up to 30 minutes)
Primary	Number of correct multiple choice responses out of 10	Participants answer 10 multiple choice questions to assess comprehension of Ted Talk video. Multiple choice questions adapted from Lee & List, 2019. Max value= 10, min value = 0. Best possible score = 10, higher scores are better.	Day 1 (Up to 30 minutes)
Secondary	ADHD-RS Home Version Score	Parents complete a 18 question assessment of child's ADHD symptoms over the past 6 months. Max score= 54, Min score= 0. Higher score indicates more ADHD symptoms.	Day 1 (Up to 30 minutes)
Secondary	Parent-reported type of ADHD	Parents indicate the type of ADHD their child presents with. Categorical variable: Inattentive, Hyperactive, or Combined	Day 1 (Up to 30 minutes)
Secondary	Type of fidget selected	4 choices of fidget are available to each participant in the experimental group. Categorical variable- fidget spinner, stress ball, pop-it, or fidget cube	Day 1 (Up to 30 minutes)